TIFACTOR 25 MICROGRAMMI/5 ML Roztwór doustny

Treść ulotki

1. TIFACTOR 25 mcg/5 ml oral solution
   1. What is TIFACTOR and what is it used for
   2. What you need to know before taking TIFACTOR
   3. How to take TIFACTOR
   4. Possible side effects
   5. How to store TIFACTOR
   6. Contents of the pack and other information
2. TIFACTOR 50 mcg/5 ml oral solution
   1. What is TIFACTOR and what is it used for
   2. What you need to know before taking TIFACTOR
   3. How to take TIFACTOR
3. TIFACTOR must be swallowed. You should take TIFACTOR on an empty stomach, usually before
   1. Possible side effects
   2. How to store TIFACTOR
   3. Contents of the pack and other information
4. TIFACTOR 100 mcg/5 ml oral solution
   1. What is TIFACTOR and what is it used for
   2. What you need to know before taking TIFACTOR
   3. How to take TIFACTOR
   4. Possible side effects
   5. How to store TIFACTOR
   6. Contents of the pack and other information

TIFACTOR 25 mcg/5 ml oral solution

Sodium levothyroxine

Read this leaflet carefully before taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What TIFACTOR is and what it is used for
• 2. What you need to know before you take TIFACTOR
• 3. How to take TIFACTOR
• 4. Possible side effects
• 5. How to store TIFACTOR
• 6. Contents of the pack and other information

1. What is TIFACTOR and what is it used for

TIFACTOR contains the active ingredient levothyroxine sodium.
It is used to treat hypothyroidism, a condition in which the thyroid gland is underactive and does not produce
enough thyroxine for the body's needs.
TIFACTOR is also used to treat thyroid cancer and diffuse non-toxic goiter or
Hashimoto's thyroiditis, conditions in which the thyroid gland enlarges causing swelling in the front
part of the neck.

2. What you need to know before taking TIFACTOR

Do not take TIFACTOR

• if you are allergic to sodium levothyroxine, sodium methyl parahydroxybenzoate or any of the other ingredients of this medicine (listed in section 6).
• If you suffer from adrenal insufficiency and do not have sufficient corticosteroid coverage
• If you have had a heart attack (acute myocardial infarction), inflammation of the heart muscle (acute myocarditis) or inflammation of the sac surrounding the heart (acute pancarditis)
• If you are pregnant, do not take this medicine in combination with other medicines to treat hyperthyroidism (see section on Pregnancy and breastfeeding)

Warnings and precautions
Talk to your doctor or pharmacist before taking TIFACTOR.

• If you have a heart condition, circulation problems or high blood pressure
• If you suffer from a very active thyroid (hyperthyroidism), an underactive adrenal gland, diabetes or have had an underactive thyroid for some time.

Children
Partial hair loss may occur during the first few months of therapy, but this effect is
temporary and usually regrowth occurs.
Extreme caution should be exercised when starting levothyroxine therapy in premature infants with low
birth weight. Due to immature adrenal function, circulatory collapse may occur
(see section 4 “Possible side effects”).

Other medicines and TIFACTOR
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
TIFACTOR can interfere with the action of some other medicines and some medicines can have an
effect on TIFACTOR. In particular, tell your doctor or pharmacist if you are taking the following
medicines:

• medicines to prevent blood from clotting (e.g. warfarin)
• medicines for depression (e.g. sertraline, imipramine, amitriptyline)
• medicines for epilepsy (e.g. phenytoin, phenobarbital, carbamazepine) or
• medicines for diabetes
• rifampicin (for infections, particularly for tuberculosis)
• digoxin or amiodarone (for the heart)
• propranolol (for high blood pressure), lovastatin (for high cholesterol levels) or phenylbutazone or aspirin
• oestrogens, products containing oestrogens or oral contraceptives, androgens or corticosteroids
• other medicines, including those bought without a prescription
• sucralfate, cimetidine or aluminium hydroxide for stomach ulcers
• cholestyramine or colesevelam to reduce cholesterol levels, sodium polystyrene sulphonate or calcium carbonate or iron supplements.

TIFACTOR can be taken with these medicines but not at the same time.

• Chloroquine or proguanil for malaria prevention
• Protease inhibitors (e.g. ritonavir, indinavir and lopinavir) used to treat HIV
• Sevelamer (used to treat high phosphate levels in the blood in patients with kidney failure)
• Tyrosine kinase inhibitors (e.g. imatinib and sunitinib) used to treat cancer
• Propylthiouracil (used to treat hyperthyroidism)
• Beta-blockers (used to treat high blood pressure and heart problems)
• Sympathomimetic agents (steroid hormones used to treat adrenal insufficiency and other diseases)
• Glucocorticoids (steroid hormones used to treat insufficiency and other diseases)
• Iodine-containing contrast agents (used to increase the visibility of blood vessels and organs during radiographic procedures)
• Orlistat (medicine used to treat obesity)

If you are hospitalised for an operation, tell the anaesthetist or medical staff
that you are taking TIFACTOR. It may react with an anaesthetic (ketamine) that may be
given to you before an operation.

TIFACTOR with food and drink
Products containing soy (mainly soy-based supplements) may interact with
levothyroxine, ask your doctor or pharmacist for advice.

Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice.

Driving and operating machinery
It is unlikely that this medicine will affect your ability to drive or operate machinery.

TIFACTOR contains sodium methyl parahydroxybenzoate (E219)

• It may cause allergic reactions (even delayed). TIFACTOR contains glycerolIt may cause headache, stomach upset and diarrhoea. TIFACTOR contains less than 1 mmol (23 mg) of sodiumper 5 ml, that is to say, essentially ‘sodium-free’.

3. How to take TIFACTOR

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.
The doctor will decide the dose to be taken every day based on your condition. The doctor will perform
blood tests at regular intervals to monitor your response to treatment.
If you switch from the oral solution to the levothyroxine tablet version or from the tablet version
to the levothyroxine oral solution, your doctor will monitor you more closely. The same applies when switching from
different brands of oral solutions containing levothyroxine.

The usual daily doses are: adults and children over 12 years of age:
The initial dose is 50-100 micrograms (mcg) per day, with increases of 25-50 mcg every 3-4
weeks, until you take the right amount for your condition. The usual maintenance dose is 100-200 mcg per day.
For diffuse non-toxic goiter or Hashimoto's thyroiditis, the recommended dose is 50-200 micrograms
(mcg) per day.
For the treatment of thyroid cancer, the recommended dose is 150-300 micrograms (mcg) per
day.

Elderly patients (over 50 years of age):
The initial dose is 12.5 micrograms (mcg) per day, with increases of 12.5 mcg every 4 weeks, until
the correct dose is obtained. The usual final dose is between 50 and 200 mcg per day. This dose
also applies to patients with severe hypothyroidism and those with heart disease.

Children under 12 years of age:
The dose for children depends on age, weight and the condition to be treated. The child will be
monitored to ensure they take the correct dose. Give this medicine to your child at least
one hour before the first meal of the day.
Congenital hypothyroidism in children:
Initially, 10-15 micrograms/kg of body weight per day for the first 3 months. The dose will then be
adjusted based on the response to treatment.
Acquired hypothyroidism in children:
Initially, 12.5-50 micrograms per day. The dose should be gradually increased every 2-4
weeks based on the response to treatment.
Use the provided oral administration syringe to release the specific dose – see the
instructions below. The syringe can be used to measure the dose by aspirating the liquid up to the correct mark
on the syringe. For example, if your dose is 50 micrograms per day, the corresponding volume
will be:

For the 25 micrograms/5 ml dosage: 2 x 5 ml (10 ml in total)
How to use the oral administration syringe:

• 1. Shake the bottle well, making sure the cap is tightly closed on the bottle.
• 2. Remove the cap. Note: keep the cap nearby to close the bottle after each use.
• 3. Push the plastic adapter into the neck of the bottle. Note: The adapter must always remain in the bottle.
• 4. Take the syringe and make sure the plunger is pushed completely down.
• 5. Hold the bottle in an upright position and firmly insert the oral administration syringe into the plastic adapter.
• 6. Turn the entire bottle with the syringe upside down.
• 7. Slowly pull the plunger down to the end so that the syringe is filled with medicine. Push the plunger up to expel any large air bubbles that may be trapped in the oral administration syringe.
• 8. Then slowly pull the plunger back to the volume necessary for your dose.
• 9. Turn the entire bottle with the syringe upright and remove the syringe from the bottle.
• 10. The medicine can now be ingested directly from the oral administration syringe. Make sure you are sitting upright and the plunger is pressed slowly to allow you to swallow the dose.
• 11. Replace the child-resistant cap after use, leaving the adapter in place.
• 12. Cleaning: after use, clean the outside of the syringe with a dry, clean cloth.

Method of administration
TIFACTOR must be swallowed. You should take TIFACTOR on an empty stomach, usually before
breakfast.

Duration of treatment
If you are being treated for hypothyroidism, diffuse non-toxic goiter or Hashimoto's thyroiditis, the duration
of treatment is usually for life.

If you take more TIFACTOR than you should
If you have accidentally taken an overdose of the medicine, call your doctor immediately or go to the
emergency room of the nearest hospital. Symptoms of overdose include fever, irregular heartbeat,
muscle cramps, headache, restlessness, hot flashes, sweating and diarrhea. Always bring
with you the remaining medicine, container and label so that the medicine can be
identified.

If you forget to take TIFACTOR
If you forget to take the medicine, take the next dose when you remember and then take the
next dose at the usual time. Do not take a double dose at the same time to make up for the
missed dose. If you have forgotten many doses, inform your doctor at the next check-up or blood test.

If you stop taking TIFACTOR
For your treatment to work, you must take TIFACTOR regularly at the dosage prescribed by
your doctor. Under no circumstances should you change, stop or interrupt the prescribed treatment without
talking to your doctor. The symptoms of the disease may return if you stop or interrupt treatment
prematurely. The nature of these symptoms depends on the underlying pathology.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Generally these occur only if you are taking a dose that is too high.

If you experience any of the following symptoms, stop taking TIFACTOR and tell your
doctor immediately or go to the nearest hospital emergency room.

• Swelling of the hands, feet, ankles, face, lips, mouth or throat that can cause difficulty swallowing or breathing.
• Hives
• Fainting
• Yellowing of the skin and eyes, also known as jaundice. These side effects are very serious. If you experience these symptoms, you may have a severe allergic reaction to TIFACTOR. You may need urgent medical attention or hospitalisation. All these various side effects are very rare.

Tell your doctor if you notice any of the following effects:
Rapid or irregular heartbeat, palpitations, chest pain, muscle cramps or weakness, headache,
restlessness, excitability, hot flushes, circulatory collapse in premature infants with low birth
weight (see section 2), sweating, diarrhoea, vomiting, fever, menstrual problems, high blood
pressure in the skull, tremor, drowsiness, intolerance to heat and excessive weight loss. Skin rash,
itching and swelling can also occur.
Very rarely, if a particularly excessive dose of TIFACTOR has been taken at once
or over many years, the heart may fail and coma and death have been reported.
If you feel unwell in any other way, tell your doctor as soon as possible.

Additional side effects in children
Children may experience hair loss at the beginning of treatment, however this is usually a
temporary effect and the hair will grow back.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-
sospetta-reazione-avversa .
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store TIFACTOR

Keep this medicine out of the sight and reach of children.

Expiry date
Discard any remaining medicine 2 months after opening.
Do not use this medicine after the expiry date which is stated on the label and the package after
EXP. The expiry date refers to the last day of that month.

Storage conditions
Do not store at a temperature above 25°C.
Store in the original package to protect the medicine from light.
Do not use this medicine if you notice that the appearance or odour of the medicine has changed. Speak to your
pharmacist.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What TIFACTOR contains

• The active ingredient is levothyroxine sodium. Each 5 ml of oral solution contains levothyroxine equivalent to 25 micrograms (mcg) of anhydrous levothyroxine sodium.
• The other ingredients are glycerol, citric acid monohydrate, sodium methyl parahydroxybenzoate (E219) and purified water.

Description of the appearance of TIFACTOR and contents of the pack
TIFACTOR is a clear and colourless liquid. Each bottle contains 75 ml or 100 ml of levothyroxine
oral solution. TIFACTOR is available in packs containing one or two glass bottles, each
filled with 75 ml of oral solution or one glass bottle filled with 100 ml of oral solution.
A 5 ml syringe is also included to help you measure the dose.

Marketing authorisation holder and manufacturer

AIC Holder
I.B.N. Savio S.r.l
Via del Mare, 36
Pomezia (RM)

Manufacturer
GALENICA PHARMACEUTICAL INDUSTRY S.A.
3rd km Old National Road Chalkida ‐ Athens
Glifa Chalkida Eubia, 34100, Greece

TIFACTOR 50 mcg/5 ml oral solution

Sodium levothyroxine

Read this leaflet carefully before taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What TIFACTOR is and what it is used for
• 2. What you need to know before you take TIFACTOR
• 3. How to take TIFACTOR
• 4. Possible side effects
• 5. How to store TIFACTOR
• 6. Contents of the pack and other information

1. What is TIFACTOR and what is it used for

TIFACTOR contains the active ingredient levothyroxine sodium.
It is used to treat hypothyroidism, a condition in which the thyroid gland is underactive and does not produce
enough thyroxine for the body's needs.
TIFACTOR is also used to treat thyroid cancer and diffuse non-toxic goiter or
Hashimoto's thyroiditis, conditions in which the thyroid gland enlarges causing swelling in the
front of the neck.

2. What you need to know before taking TIFACTOR

Do not take TIFACTOR

• if you are allergic to levothyroxine sodium, sodium methyl parahydroxybenzoate or any of the other ingredients of this medicine (listed in section 6).
• If you suffer from adrenal insufficiency and do not have sufficient corticosteroid coverage
• If you have had a heart attack (acute myocardial infarction), inflammation of the heart muscle (acute myocarditis) or inflammation of the sac surrounding the heart (acute pericarditis)
• If you are pregnant, do not take this medicine in combination with other medicines to treat hyperthyroidism (see section on Pregnancy and breastfeeding)

Warnings and precautions
Talk to your doctor or pharmacist before taking TIFACTOR.

• If you have heart disease, circulation problems or high blood pressure
• If you suffer from a very active thyroid (hyperthyroidism), an underactive adrenal gland, diabetes or have had an underactive thyroid for some time.

Children
Partial hair loss may occur during the first few months of therapy, but this effect is
temporary and usually regrowth occurs.
Extreme caution should be exercised when starting therapy with levothyroxine in premature infants with low
birth weight. Due to immature adrenal function, circulatory collapse may occur
(see section 4 “Possible side effects”).

Other medicines and TIFACTOR
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
TIFACTOR can interfere with the action of some other medicines and some medicines can have an
effect on TIFACTOR. In particular, tell your doctor or pharmacist if you are taking the following
medicines:

• medicines to prevent blood from clotting (e.g. warfarin)
• medicines for depression (e.g. sertraline, imipramine, amitriptyline)
• medicines for epilepsy (e.g. phenytoin, phenobarbital, carbamazepine) or
• medicines for diabetes
• rifampicin (for infections, particularly for tuberculosis)
• digoxin or amiodarone (for the heart)
• propranolol (for high blood pressure), lovastatin (for high cholesterol levels) or phenylbutazone or aspirin
• oestrogens, products containing oestrogens or oral contraceptives, androgens or corticosteroids
• other medicines, including those bought without a prescription
• sucralfate, cimetidine or aluminium hydroxide for stomach ulcers
• cholestyramine or colesevelam to reduce cholesterol levels, sodium polystyrene sulphonate or calcium carbonate or iron supplements.

TIFACTOR can be taken with these medicines but not at the same time.

• Chloroquine or proguanil for malaria prevention
• Protease inhibitors (e.g. ritonavir, indinavir and lopinavir) used to treat HIV
• Sevelamer (used to treat high phosphate levels in the blood in patients with kidney failure)
• Tyrosine kinase inhibitors (e.g. imatinib and sunitinib) used to treat cancer
• Propylthiouracil (used to treat hyperthyroidism)
• Beta-blockers (used to treat high blood pressure and heart problems)
• Sympathomimetic agents (steroid hormones used to treat adrenal insufficiency and other diseases)
• Glucocorticoids (steroid hormones used to treat insufficiency and other diseases)
• Iodine-containing contrast agents (used to increase the visibility of blood vessels and organs during radiographic procedures)
• Orlistat (medicine used to treat obesity)

If you are admitted to hospital for an operation, tell the anaesthetist or medical staff
that you are taking TIFACTOR. It may react with an anaesthetic (ketamine) that may be
given to you before an operation.

TIFACTOR with food and drink
Products containing soy (mainly soy-based supplements) may interact with
levothyroxine, ask your doctor or pharmacist for advice.

Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist for advice.

Driving and operating machinery
It is unlikely that the medicine will affect your ability to drive or operate machinery.

TIFACTOR contains sodium methyl parahydroxybenzoate (E219)

• It may cause allergic reactions (even delayed ones). TIFACTOR contains glycerolIt may cause headache, stomach upset and diarrhoea. TIFACTOR contains less than 1 mmol (23 mg) of sodiumper 5 ml, i.e. essentially ‘sodium-free’.

3. How to take TIFACTOR

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.
The doctor will decide the dose to be taken each day based on your condition. The doctor will perform
blood tests at regular intervals to monitor your response to treatment.
If you switch from the oral solution to the tablet version of levothyroxine or from the tablet
version to the oral solution of levothyroxine, your doctor will monitor you more closely. The same applies when switching from
different brands of oral solutions containing levothyroxine.

The usual daily doses are: adults and children over 12 years of age:
The initial dose is 50-100 micrograms (mcg) per day, with increases of 25-50 mcg every 3-4
weeks, until you take the right amount for your condition. The usual maintenance dose is 100-200 mcg per day.
For diffuse non-toxic goiter or Hashimoto's thyroiditis, the recommended dose is 50-200 micrograms
(mcg) per day.
For the treatment of thyroid cancer, the recommended dose is 150-300 micrograms (mcg) per
day.

Elderly patients (over 50 years of age):
The initial dose is 12.5 micrograms (mcg) per day, with increases of 12.5 mcg every 4 weeks, until
the correct dose is obtained. The usual final dose is between 50 and 200 mcg per day. This dose
also applies to patients with severe hypothyroidism and those with heart disease.

Children under 12 years of age:
The dose for children depends on age, weight and the condition being treated. The child will be
monitored to ensure they take the correct dose. Give this medicine to your child at least
one hour before the first meal of the day.
Congenital hypothyroidism in children:
Initially, 10-15 micrograms/kg of body weight per day for the first 3 months. The dose will then
be adjusted based on the response to treatment.
Acquired hypothyroidism in children:
Initially, 12.5-50 micrograms per day. The dose should be gradually increased every 2-4
weeks based on the response to treatment.
Use the provided oral administration syringe to release the specific dose – see instructions below. The syringe can be used to measure the dose by aspirating the liquid up to the correct mark
on the syringe. For example, if your dose is 50 micrograms per day, the corresponding volume
will be:

For the dosage 50 micrograms/5 ml: 5 ml
How to use the oral administration syringe:

• 13. Shake the bottle well, making sure the cap is tightly closed on the bottle.
• 14. Remove the cap. Note: keep the cap close by to close the bottle after each use.
• 15. Push the plastic adapter into the neck of the bottle. Note: The adapter must always remain in the bottle.
• 16. Take the syringe and make sure the plunger is fully depressed.
• 17. Hold the bottle in an upright position and firmly insert the oral administration syringe into the plastic adapter.
• 18. Turn the entire bottle upside down with the syringe inverted.
• 19. Slowly pull the plunger down to the end so that the syringe fills with medicine. Push the plunger up to expel large air bubbles that may be trapped in the oral administration syringe.
• 20. Then slowly pull the plunger back to the volume needed for your dose.
• 21. Turn the entire bottle with the syringe upright and remove the syringe from the bottle.
• 22. The medicine can now be ingested directly from the oral administration syringe. Make sure you are sitting upright and the plunger is pressed slowly to allow you to swallow the dose.
• 23. Replace the child-resistant cap after use, leaving the adapter in place.
• 24. Cleaning: after use, clean the outside of the syringe with a dry, clean cloth.

Method of administration

TIFACTOR must be swallowed. You should take TIFACTOR on an empty stomach, usually before

breakfast.

Duration of treatment
If you are being treated for hypothyroidism, diffuse non-toxic goiter or Hashimoto's thyroiditis, the duration
of treatment is generally for life.

If you take more TIFACTOR than you should
If you have accidentally taken an overdose of the medicine, call your doctor immediately or go to the
emergency room of the nearest hospital. Symptoms of overdose include fever, irregular heartbeat,
muscle cramps, headache, restlessness, hot flushes, sweating and diarrhea. Always bring
with you the remaining medicine, the container and the label so that the medicine can be
identified.

If you forget to take TIFACTOR
If you forget to take the medicine, take the next dose when you remember and then take the
next dose at the usual time. Do not take a double dose at the same time to make up for the
forgotten dose. If you have forgotten many doses, inform your doctor at your next check-up or blood test.

If you stop taking TIFACTOR
For your treatment to work, you must take TIFACTOR regularly at the dosage prescribed by
your doctor. Under no circumstances should you change, suspend or stop the prescribed treatment without
talking to your doctor. The symptoms of the disease may return if you stop or interrupt treatment
prematurely. The nature of these symptoms depends on the underlying condition.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
These generally occur only if you are taking a dose that is too high.

If you experience any of the following symptoms, stop taking TIFACTORand immediately inform your doctor or go to the nearest hospital emergency room.

• Swelling of the hands, feet, ankles, face, lips, mouth or throat that can cause difficulty swallowing or breathing.
• Hives
• Fainting
• Yellowing of the skin and eyes, also known as jaundice. These side effects are very serious. If you experience these symptoms, you may have a severe allergic reaction to TIFACTOR. You may need urgent medical attention or hospitalisation. All these various side effects are very rare.

Tell your doctor if you notice any of the following effects:
Rapid or irregular heartbeat, palpitations, chest pain, muscle cramps or weakness, headache,
restlessness, excitability, hot flushes, circulatory collapse in premature infants with low birth
weight (see section 2), sweating, diarrhoea, vomiting, fever, menstrual problems, high blood
pressure in the skull, tremor, drowsiness, intolerance to heat and excessive weight loss. Skin rash,
itching and swelling may also occur.
Very rarely, if a particularly excessive dose of TIFACTOR has been taken at once
or over many years, the heart may fail and coma and death have been reported.
If you feel unwell in any other way, tell your doctor as soon as possible.

Additional side effects in children
Children may experience hair loss at the beginning of treatment, however this is usually
a temporary effect and the hair grows back.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly
through the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-
sospetta-reazione-avversa .
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store TIFACTOR

Keep this medicine out of the sight and reach of children.

Expiry date
Discard any remaining medicine 2 months after opening.
Do not use this medicine after the expiry date which is stated on the label and the packaging after
EXP. The expiry date refers to the last day of that month.

Storage conditions
Do not store at a temperature above 25°C.
Store in the original packaging to protect the medicine from light.
Do not use this medicine if you notice that the appearance or odour of the medicine has changed. Speak to your
pharmacist.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What TIFACTOR contains

• The active substance is levothyroxine sodium. Each 5 ml of oral solution contains levothyroxine equivalent to 50 micrograms (mcg) of anhydrous levothyroxine sodium.
• The other ingredients are glycerol, citric acid monohydrate, sodium methyl parahydroxybenzoate (E219) and purified water.

Description of the appearance of TIFACTOR and contents of the pack
TIFACTOR is a transparent and colorless liquid. Each bottle contains 75 ml or 100 ml of levothyroxine
oral solution. TIFACTOR is available in packs containing one or two glass bottles, each
filled with 75 ml of oral solution or one glass bottle filled with 100 ml of oral solution
A 5 ml syringe is also included to help you measure the dose.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
I.B.N. Savio S.r.l
Via del Mare, 36
Pomezia (RM)

Manufacturer
GALENICA PHARMACEUTICAL INDUSTRY S.A.
3rd km Old National Road Chalkida ‐ Atene
Glifa Chalkida Eubia, 34100, Greece

TIFACTOR 100 mcg/5 ml oral solution

Sodium levothyroxine

Read this leaflet carefully before you start to take this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What TIFACTOR is and what it is used for
• 2. What you need to know before you take TIFACTOR
• 3. How to take TIFACTOR

• 4. Possible side effects
• 5. How to store TIFACTOR
• 6. Contents of the pack and other information

1. What is TIFACTOR and what is it used for

TIFACTOR contains the active ingredient levothyroxine sodium.
It is used to treat hypothyroidism, a condition in which the thyroid gland is underactive and does not produce
enough thyroxine for the body's needs.
TIFACTOR is also used to treat thyroid cancer and diffuse non-toxic goiter or
Hashimoto's thyroiditis, conditions in which the thyroid gland enlarges causing swelling in the front
of the neck.

2. What you need to know before taking TIFACTOR

Do not take TIFACTOR

• if you are allergic to levothyroxine sodium, sodium methyl parahydroxybenzoate or any of the other ingredients of this medicine (listed in section 6).
• If you suffer from adrenal insufficiency and do not have sufficient corticosteroid coverage
• If you have had a heart attack (acute myocardial infarction), inflammation of the heart muscle (acute myocarditis) or inflammation of the sac surrounding the heart (acute pericardiitis)
• If you are pregnant, do not take this medicine in association with other medicines to treat hyperthyroidism (see section on Pregnancy and breastfeeding)

Warnings and precautions
Talk to your doctor or pharmacist before taking TIFACTOR.

• If you have heart disease, circulation problems or high blood pressure
• If you suffer from a very active thyroid (hyperthyroidism), an underactive adrenal gland, diabetes or have had an underactive thyroid for some time.

Children
Some hair loss may occur during the first few months of therapy, but this effect is
temporary and usually regrowth occurs.
Extreme caution should be exercised when starting levothyroxine therapy in premature infants with low
birth weight. Due to immature adrenal function, circulatory collapse may occur
(see section 4 “Possible side effects”).

Other medicines and TIFACTOR
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
TIFACTOR can interfere with the action of some other medicines and some medicines can have an
effect on TIFACTOR. In particular, tell your doctor or pharmacist if you are taking the following
medicines:

• medicines to prevent blood from clotting (e.g. warfarin)
• medicines for depression (e.g. sertraline, imipramine, amitriptyline)
• medicines for epilepsy (e.g. phenytoin, phenobarbital, carbamazepine) or
• medicines for diabetes
• rifampicin (for infections, especially for tuberculosis)
• digoxin or amiodarone (for the heart)
• propranolol (for high blood pressure), lovastatin (for high cholesterol levels) or phenylbutazone or aspirin
• oestrogens, products containing oestrogens or oral contraceptives, androgens or corticosteroids
• other medicines, including those bought without a prescription
• sucralfate, cimetidine or aluminium hydroxide for stomach ulcers
• cholestyramine or colesevelam to reduce cholesterol levels, sodium polystyrene sulphonate or calcium carbonate or iron supplements.

TIFACTOR can be taken with these medicines but not at the same time.

• Chloroquine or proguanil for malaria prevention
• Protease inhibitors (e.g. ritonavir, indinavir and lopinavir) used to treat HIV
• Sevelamer (used to treat high phosphate levels in the blood in patients with kidney failure)
• Tyrosine kinase inhibitors (e.g. imatinib and sunitinib) used to treat cancer
• Propylthiouracil (used to treat hyperthyroidism)
• Beta-blockers (used to treat high blood pressure and heart problems)
• Sympathomimetic agents (steroid hormones used to treat adrenal insufficiency and other diseases)
• Glucocorticoids (steroid hormones used to treat insufficiency and other diseases)
• Iodine-containing contrast agents (used to increase the visibility of blood vessels and organs during radiographic procedures)
• Orlistat (medicine used to treat obesity)

If you are admitted to hospital for surgery, tell the anaesthetist or medical staff
that you are taking TIFACTOR. It may react with an anaesthetic (ketamine) that may be
given to you before an operation.

TIFACTOR with food and drink
Products containing soy (mainly soy-based supplements) may interact with
levothyroxine, ask your doctor or pharmacist for advice.

Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
If you are pregnant, suspect you are pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice.

Driving and operating machinery
It is unlikely that the medicine will affect your ability to drive or operate machinery.

TIFACTOR contains sodium methyl parahydroxybenzoate (E219)

• It may cause allergic reactions (even delayed). TIFACTOR contains glycerolIt may cause headache, stomach upset and diarrhoea. TIFACTOR contains less than 1 mmol (23 mg) of sodium per 5 ml, i.e. essentially ‘sodium-free’.

3. How to take TIFACTOR

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
The doctor will decide the dose to be taken every day based on your condition. The doctor will perform
blood tests at regular intervals to monitor your response to treatment.
If you switch from the oral solution to the levothyroxine tablet version or from the tablet version
to the levothyroxine oral solution, your doctor will monitor you more closely. The same applies when switching from
different brands of oral solutions containing levothyroxine.

The usual daily doses are: adults and children over 12 years:
The initial dose is 50-100 micrograms (mcg) per day, with increases of 25-50 mcg every 3-4
weeks, until you take the right amount for your condition. The usual maintenance dose is 100-200 mcg per day.
For diffuse non-toxic goiter or Hashimoto's thyroiditis, the recommended dose is 50-200 micrograms
(mcg) per day.
For the treatment of thyroid cancer, the recommended dose is 150-300 micrograms (mcg) per
day.

Elderly patients (over 50 years of age):
The initial dose is 12.5 micrograms (mcg) per day, with increases of 12.5 mcg every 4 weeks, until
the correct dose is obtained. The usual final dose is between 50 and 200 mcg per day. This dose
also applies to patients with severe hypothyroidism and those with heart disease.

Children under 12 years:
The dose for children depends on age, weight and the condition being treated. The child will be
monitored to ensure they are taking the correct dose. Give this medicine to your child at least
one hour before the first meal of the day.
Congenital hypothyroidism in children:
Initially, 10-15 micrograms/kg of body weight per day for the first 3 months. The dose will then
be adjusted based on the response to treatment.
Acquired hypothyroidism in children:
Initially, 12.5-50 micrograms per day. The dose should be gradually increased every 2-4
weeks based on the response to treatment.
Use the supplied oral administration syringe to release the specific dose – see instructions below. The syringe can be used to measure the dose by aspirating the liquid up to the correct mark
on the syringe. For example, if your dose is 50 micrograms per day, the corresponding volume
will be:

For 100 micrograms/5 ml dosage: 2.5 ml
How to use the oral administration syringe:

• 25. Shake the bottle well, making sure the cap is tightly closed on the bottle.
• 26. Remove the cap. Note: keep the cap close by to close the bottle after each use.
• 27. Push the plastic adapter into the neck of the bottle. Note: The adapter must always remain in the bottle.
• 28. Take the syringe and make sure the plunger is pushed completely down.
• 29. Hold the bottle in an upright position and firmly insert the oral administration syringe into the plastic adapter.
• 30. Turn the entire bottle upside down with the syringe inverted.

• 31. Slowly pull the plunger down to the end so that the syringe is filled with medicine. Push the plunger up to expel large air bubbles that may be trapped in the oral administration syringe.
• 32. Then slowly pull the plunger back to the volume needed for your dose.
• 33. Turn the entire bottle with the syringe upright and remove the syringe from the bottle.
• 34. The medicine can now be swallowed directly from the oral administration syringe. Make sure you are sitting upright and the plunger is pressed slowly to allow you to swallow the dose.
• 35. Replace the child-resistant cap after use, leaving the adapter in place.
• 36. Cleaning: after use, clean the outside of the syringe with a dry, clean cloth.

Method of administration
TIFACTOR must be swallowed. You should take TIFACTOR on an empty stomach, usually before
breakfast.

Duration of treatment
If you are being treated for hypothyroidism, diffuse non-toxic goiter or Hashimoto's thyroiditis, the duration
of treatment is usually for life.

If you take more TIFACTOR than you should
If you have accidentally taken an overdose of the medicine, call your doctor immediately or go to the
emergency room of the nearest hospital. Symptoms of overdose include fever, irregular heartbeat,
muscle cramps, headache, restlessness, flushing, sweating and diarrhea. Always bring
with you the remaining medicine, container and label so that the medicine can be
identified.

If you forget to take TIFACTOR
If you forget to take the medicine, take the next dose when you remember and then take the
next dose at the usual time. Do not take a double dose at the same time to make up for the
forgotten dose. If you have forgotten many doses, inform your doctor at the next check-up or blood test.

If you stop taking TIFACTOR
For your treatment to work, you must take TIFACTOR regularly at the dosage prescribed by
your doctor. Under no circumstances should you change, suspend or stop the prescribed treatment without
talking to your doctor. The symptoms of the disease may return if you stop or interrupt treatment
prematurely. The nature of these symptoms depends on the underlying pathology.
If you have any doubts about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Generally, these occur only if you are taking a dose that is too high.

If any of the following symptoms occur, stop taking TIFACTOR and immediately inform your doctor or go to the nearest hospital emergency room.

• Swelling of the hands, feet, ankles, face, lips, mouth or throat that can cause difficulty swallowing or breathing.
• Hives
• Fainting
• Yellowing of the skin and eyes, also known as jaundice

These side effects are very serious. If you experience these symptoms, you may have a severe allergic reaction to TIFACTOR. You may need urgent medical attention or hospitalisation. All these various side effects are very rare.
Tell your doctor if you notice any of the following effects:
Rapid or irregular heartbeat, palpitations, chest pain, muscle cramps or weakness, headache, restlessness, excitability, hot flushes, circulatory collapse in premature infants with low birth weight (see section 2), sweating, diarrhoea, vomiting, fever, menstrual problems, high blood pressure in the skull, tremor, drowsiness, intolerance to heat and excessive weight loss. Skin rash, itching and swelling may also occur.
Very rarely, if a particularly excessive dose of TIFACTOR has been taken at once or over many years, the heart may fail and coma and death have been reported.
If you feel unwell in any other way, tell your doctor as soon as possible.

Additional side effects in children
Children may experience hair loss at the beginning of treatment, however this is usually a temporary effect and the hair grows back.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-
sospetta-reazione-avversa .
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store TIFACTOR

Keep this medicine out of the sight and reach of children.

Expiry date
Discard any remaining medicine 2 months after opening.
Do not use this medicine after the expiry date which is stated on the label and the packaging after
EXP. The expiry date refers to the last day of that month.

Storage conditions
Do not store at a temperature above 25°C.
Store in the original packaging to protect the medicine from light.
Do not use this medicine if you notice that the appearance or odour of the medicine has changed. Speak to your
pharmacist.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What TIFACTOR contains

• The active ingredient is levothyroxine sodium. Each 5 ml of oral solution contains levothyroxine equivalent to 100 micrograms (mcg) of anhydrous levothyroxine sodium.
• The other ingredients are glycerol, citric acid monohydrate, sodium methyl parahydroxybenzoate (E219) and purified water.

Description of the appearance of TIFACTOR and contents of the pack
TIFACTOR is a transparent and colourless liquid. Each bottle contains 75 ml or 100 ml of levothyroxine
oral solution. TIFACTOR is available in packs containing one or two glass bottles, each
filled with 75 ml of oral solution or one glass bottle filled with 100 ml of oral solution.
A 5 ml syringe is also included to help you measure the dose.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
I.B.N. Savio S.r.l
Via del Mare, 36
Pomezia (RM)

Manufacturer
GALENICA PHARMACEUTICAL INDUSTRY S.A.
3rd km Old National Road Chalkida ‐ Atene
Glifa Chalkida Eubia, 34100, Greece